Merlin™ EX3100Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 05414734503105), received between Aug 27, 2018 and May 31, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “No Pacing” (8 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2026Loose or Intermittent Connection; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE DISLODGEMENT OCCURRED DURING STYLET REMOVAL AND WAS CONFIRMED INTRAOPERATIVELY UNDER FLUOROSCOPY IN THE CATHETERIZATION LABORATORY. AFTER DISLODGEMENT, THE LEAD WAS REMOVED ONCE, AND THE SCREW WAS CONFIRMED TO BE NORMAL. DURING A SUBSEQUENT ATTEMPT TO RE IMPLANT IN THE RIGHT ATRIAL APPENDAGE, PACING SYSTEM ANALYZER (PSA) MEASUREMENTS PRIOR TO SCREW FIXATION COULD NOT BE PERFORMED. UPON CONNECTING THE THRESHOLD CABLE, NO WAVEFORM WAS OBTAINED, AND NO PACING OUTPUT WAS OBSERVED. THE RA LEAD WAS SUSPECTED TO BE DAMAGED. THE RA LEAD IS NOT USED AND REPLACED. THE PSA WAS NOT USED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25344454 ↗
• MalfunctionNov 19, 2025Connection Problem; Connection Problem

  DURING AN INITIAL IMPLANT PROCEDURE, LOSS OF PACING WAS OBSERVED ON THE PACING SYSTEM ANALYZER (PSA) DUE TO AN INTERRUPTED CONNECTION. THE PSA WAS USED THROUGHOUT THE ENTIRE PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593449 ↗
• MalfunctionOct 31, 2025Failure to Capture; Failure to Sense; Failure to Capture; Failure to Sense

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE MERLIN PACING SYSTEM ANALYZER (PSA) FAILED TO OBTAIN CAPTURE THRESHOLDS AND TO SENSE. THE ANALYZER WAS REPLACED DURING THE PROCEDURE. THE PATIENT'S CONDITION WAS NOTED AS HAVING SUFFERED NO CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438949 ↗
• MalfunctionAug 26, 2025No Pacing; No Pacing

  IT WAS REPORTED THAT THE PACING SYSTEM ANALYZER (PSA) WAS NOT SUPPORTING IN BACKUP PACING WHEN THE PROGRAMMER WAS SWITCHED OFF DURING PROCEDURE. THE PSA WAS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901294 ↗
• MalfunctionAug 18, 2025Loose or Intermittent Connection; No Pacing; Loose or Intermittent Connection; No Pacing

  IT WAS REPORTED THAT THE PACING SYSTEM ANALYZER (PSA) WAS NOT SUPPORTING IN BACKUP PACING WHEN THE PROGRAMMER WAS SWITCHED OFF DURING PROCEDURE. THE PSA AND ITS ADAPTER WAS NOT IN GOOD CONTACT RESULTING IN VARYING MEASUREMENTS AT THE TIME OF PROCEDURE. THE PATIENT WAS DISCHARGED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824937 ↗
• MalfunctionJul 23, 2025Failure to Capture; Failure to Sense; Failure to Capture; Failure to Sense

  IT WAS REPORTED THAT DURING AN INITIAL IMPLANT PROCEDURE, THE PACING SYSTEM ANALYZER (PSA) HAD FAILED TO DELIVER CAPTURE AND SENSE THROUGH ATRIAL PORT UPON MEASURING PARAMETERS. VENTRICULAR PORT OF TRIFURCATION WAS USED INSTEAD. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22573477 ↗
• MalfunctionJan 20, 2025Failure to Capture; Incorrect Measurement; Failure to Sense; Failure to Capture; Incorrect Measurement; Failure to Sense

  IT WAS REPORTED THAT DURING THE PROCEDURE MERLIN PACING SYSTEM ANALYZER (PSA) WAS NOT PROPERLY FUNCTIONING. IT FAILED TO SENSE AND TO CAPTURE. IT WAS NOTED AS WELL THAT NO IMPEDANCE MEASUREMENTS WERE BEING DISPLAYED. NO INTERVENTION WAS REPORTED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193320 ↗
• MalfunctionJan 3, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE PACING SYSTEM ANALYZER (PSA) EXHIBITED BURNT LIGHTS, AND DAMAGED CABLES AND BATTERY. THE PSA WAS NOT USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074256 ↗
• MalfunctionJan 3, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE PACING SYSTEM ANALYZER (PSA) EXHIBITED BURNT LIGHTS, AND DAMAGED CABLES AND BATTERY. THE PSA WAS NOT USED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074254 ↗
• MalfunctionJan 2, 2025Break; Thermal Decomposition of Device; Break; Thermal Decomposition of Device

  IT WAS REPORTED THE MERLIN PACING SYSTEM ANALYZER EXHIBITED BURNT LEDS, DAMAGED CABLES, AND A DAMAGED, CORROSIVE, RUSTY BATTERY COMPARTMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063374 ↗
• MalfunctionDec 2, 2024Loose or Intermittent Connection; No Pacing; Loose or Intermittent Connection; No Pacing

  IT WAS NOTED THAT THE MERLIN PACING SYSTEM ANALYZER (PSA) WAS FAILED TO PACE AND HAVING UNSPECIFIED FITTING ISSUE. THE PSA WAS NOT USED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20818320 ↗
• InjuryJan 16, 2023Unintended Electrical Shock; Unintended Electrical Shock

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2023-02285. IT WAS REPORTED THAT THE PROGRAMMER SHOCKED THE HEALTHCARE PROFESSIONAL VIA THE PROGRAMMER. THERE WAS NO PATIENT INVOLVED.

  Patient problems: Discomfort

  MAUDE report 16179865 ↗
• MalfunctionNov 30, 2022Failure to Sense; Insufficient Device Problem Information; No Pacing; Failure to Sense; Insufficient Device Problem Information; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PACING SYSTEM ANALYZER DID NOT WORK. NO INTERVENTION WAS PERFORMED. THE PATIENT WAS DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15891064 ↗
• MalfunctionNov 23, 2022Incorrect, Inadequate or Imprecise Result or Readings; No Pacing; Incorrect, Inadequate or Imprecise Result or Readings; No Pacing

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PACING SYSTEM ANALYZER (PSA) THAT WAS CONNECTED TO THE PATIENT EXHIBITED NO LOW VOLTAGE OUTPUT AND FAILED TO DO THE MEASUREMENT. THE TEST CONTINUED WITH OTHER METHOD WITH A GOOD MEASUREMENT RESULT. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859521 ↗
• MalfunctionSep 12, 2022No Pacing; No Pacing

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-37749. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A SCHEDULED PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MERLIN PACING SYSTEM ANALYZERS (PSA) WAS FAILING TO PROVIDE TEMPORARY PACING SUPPORT AND FAILING TO MEASURE SENSING, IMPEDANCE AND CAPTURE. THE PSA WAS NOT USED AND REPLACED WITH SECOND PSA, IT WAS FAILING TO PROVIDE TEMPORARY PACING SUPPORT AND FAILING TO GIVE THE MEASUREMENTS AS WELL. THE PHYSICIAN CONTINUE TO USE THIRD PSA AND COMPLETED THE PROCEDURE. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15399589 ↗
• MalfunctionAug 16, 2022Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings; Failure to Capture; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN IMPLANT PROCEDURE. IT WAS NOTED THAT THE PACING SYSTEM ANALYZER (PSA) DID NOT MEASURE THE PARAMETERS OF THE ATRIAL AND THE VENTRICULAR LEAD PROPERLY. THE PSA ALSO FAILED TO CAPTURE. THE PHYSICIAN ELECTED TO USE A PSA WAND. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15233664 ↗
• MalfunctionMay 24, 2022Connection Problem; No Pacing; Connection Problem; No Pacing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR AN IMPLANT. DURING THE PROCEDURE, THE PACING SYSTEM ANALYZER (PSA) UNEXPECTEDLY DISCONNECTED AND WAS UNABLE TO PROVIDE PACING SUPPORT. THE PSA WAS REPLACED AND THE IMPLANT PROCEDURE WAS SUCCESSFUL. THE PATIENT WAS STABLE THROUGHOUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14484544 ↗
• MalfunctionAug 27, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

  Patient problems: No Information

  MAUDE report 7820738 ↗